Systems and methods for making and using tip electrodes for leads of electrical stimulation systems

ABSTRACT

An implantable electrical stimulation lead includes a lead body, electrodes disposed along a distal end of the lead body, terminals disposed along the proximal end of the lead body, and conductors coupling the terminals to the electrodes. The electrodes include a tip electrode having an electrode body with an outer stimulating surface. An internal lumen is defined in the electrode body and extends inwardly from an opening, in a proximal end of the electrode body. Side apertures are formed between the outer stimulating surface and the internal lumen. A portion of the lead body is disposed within the internal lumen and side apertures through the opening in the proximal end of the electrode body. That portion of the lead body facilitates retention of the tip electrode on a distal tip of the lead body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims is a divisional of U.S. patent application Ser.No. 14/265,306 filed Apr. 29, 2014 which claims the benefit under 35U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No.61/823,743 filed May 15, 2013, both of which are incorporated herein byreference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed implantable electrical stimulationsystems with leads having tip electrodes, as well as methods of makingand using the leads, tip electrodes, and electrical stimulation systems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

In one embodiment, an implantable electrical stimulation lead includes alead body having a proximal end portion, a distal end portion, a distaltip, and a longitudinal length. A plurality of electrodes is disposedalong the distal end portion of the lead body. The plurality ofelectrodes includes a tip electrode disposed on the distal tip of thelead body. The tip electrode includes an electrode body having an outerstimulating surface, a proximal end, a closed distal end, acircumference, and a longitudinal length. An internal lumen is definedin the electrode body and extends inwardly from an opening in theproximal end of the electrode body. A plurality of side apertures isformed through the outer stimulating surface and opens into the internallumen. A portion of the lead body is disposed within the internal lumenand the side apertures through the opening in the proximal end of theelectrode body. The portion of the lead body within the internal lumenand the side apertures facilitates retention of the tip electrode on thedistal tip of the lead body. A plurality of terminals is disposed alongthe proximal end portion of the lead body. A plurality of conductorselectrically couples each of the plurality of terminals to at least oneof the plurality of electrodes.

In another embodiment, an implantable electrical stimulation leadincludes a lead body having a proximal end portion, a distal endportion, a distal tip, and a longitudinal length. A plurality ofelectrodes is disposed along the distal end portion of the lead body.The plurality of electrodes includes a tip electrode disposed on thedistal tip of the lead body. The tip electrode includes an electrodebody having an outer stimulating surface, a proximal end, a closeddistal end, a circumference, and a longitudinal length. An internallumen is defined in the electrode body and extends inwardly from anopening in the proximal end of the electrode body. The internal lumendefines a plurality of longitudinal grooves that extend deeper into theelectrode body than adjacent portions of the internal lumen. Each of theplurality of longitudinal grooves extends along the inner surface in adirection that is parallel to the longitudinal length of the electrodebody. A portion of the lead body is disposed within the internal lumenand the longitudinal grooves through the opening in the proximal end ofthe electrode body. The portion of the lead body within the internallumen and the longitudinal grooves facilitates retention of the tipelectrode on the distal tip of the lead body and hinders rotation of thetip electrode around the distal tip of the lead body. A plurality ofterminals is disposed along the proximal end portion of the lead body. Aplurality of conductors electrically couples each of the plurality ofterminals to at least one of the plurality of electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system that includes a lead electrically coupled to acontrol module, according to the invention:

FIG. 2A is a schematic view of one embodiment of the control module ofFIG. 1 configured and arranged to electrically couple to an elongateddevice, according to the invention:

FIG. 2B is a schematic view of one embodiment of a lead extensionconfigured and arranged to electrically couple the elongated device ofFIG. 2A to the control module of FIG. 1, according to the invention;

FIG. 3 is a schematic side view of one embodiment of a distal endportion and a proximal end portion of a lead body, the lead body havinga tip electrode and circumferential electrodes disposed along the distalend portion and terminals disposed along the proximal end portion,according to the invention;

FIG. 4A is a schematic perspective view of one embodiment of the tipelectrode of FIG. 3, the tip electrode including a channel and multipleside apertures defined along an internal lumen of the tip electrode,according to the invention;

FIG. 4B is a schematic longitudinal cross-sectional view of oneembodiment of the tip electrode of FIG. 4A, the tip electrode includinga channel and multiple side apertures defined along an internal lumen ofthe tip electrode, according, to the invention:

FIG. 5A is a schematic perspective view of another embodiment of a tipelectrode, the tip electrode including a channel and multiplelongitudinal grooves defined along an internal lumen of the tipelectrode, according to the invention;

FIG. 5B is a schematic longitudinal cross-sectional view of oneembodiment of the tip electrode of FIG. 5A, the tip electrode includinga channel and multiple longitudinal grooves defined along an internallumen of the tip electrode, according to the invention;

FIG. 6 is a schematic overview of one embodiment of components of astimulation system, including an electronic subassembly disposed withina control module, according to the invention;

FIG. 7 is a schematic side view of one embodiment of a device for brainstimulation, according to the invention:

FIG. 8A is a perspective view of an embodiment of a portion of a leadhaving a plurality of segmented electrodes, according to the invention;

FIG. 8B is a perspective view of a second embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 8C is a perspective view of a third embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 8D is a perspective view of a fourth embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention; and

FIG. 8E is a perspective view of a fifth embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed implantable electrical stimulationsystems with leads having tip electrodes, as well as methods of makingand using the leads, tip electrodes, and electrical stimulation systems.

Suitable implantable electrical stimulation systems include, but are notlimited to, at least one lead with one or more electrodes disposed alonga distal end of the lead and one or more terminals disposed along theone or more proximal ends of the lead. Leads include, for example,percutaneous leads, paddle leads, and cuff leads. Examples of electricalstimulation systems with leads are found in, for example, U.S. Pat. Nos.6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395;7,244,150; 7,672,734; 7,761,165; 7,974,706; 8,175,710; 8,224,450; and8,364,278; and U.S. Patent Application Publication No. 2007/0150036, allof which are incorporated by reference.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102 and a lead103 coupleable to the control module 102. The lead 103 includes one ormore lead bodies 106, an array of electrodes 133, such as electrode 134,and an array of terminals (e.g., 210 in FIG. 2A-2B) disposed along theone or more lead bodies 106. In at least some embodiments, the lead isisodiametric along a longitudinal length of the lead body 106.

The lead 103 can be coupled to the control module 102 in any suitablemanner. In at least some embodiments, the lead 103 couples directly tothe control module 102. In at least some other embodiments, the lead 103couples to the control module 102 via one or more intermediate devices(200 in FIGS. 2A-2B). For example, in at least some embodiments one ormore lead extensions 224 (see e.g., FIG. 2B) can be disposed between thelead 103 and the control module 102 to extend the distance between thelead 103 and the control module 102. Other intermediate devices may beused in addition to, or in lieu of, one or more lead extensionsincluding, for example, a splitter, an adaptor, or the like orcombinations thereof. It will be understood that, in the case where theelectrical stimulation system 100 includes multiple elongated devicesdisposed between the lead 103 and the control module 102, theintermediate devices may be configured into any suitable arrangement.

In FIG. 1, the electrical stimulation system 100 is shown having asplitter 107 configured and arranged for facilitating coupling of thelead 103 to the control module 102. The splitter 107 includes a splitterconnector 108 configured to couple to a proximal end of the lead 103,and one or more splitter tails 109 a and 109 b configured and arrangedto couple to the control module 102 (or another splitter, a leadextension, an adaptor, or the like).

The control module 102 typically includes a connector housing 112 and asealed electronics housing 114. An electronic subassembly 110 and anoptional power source 120 are disposed in the electronics housing 114. Acontrol module connector 144 is disposed in the connector housing 112.The control module connector 144 is configured and arranged to make anelectrical connection between the lead 103 and the electronicsubassembly 110 of the control module 102.

The electrical stimulation system or components of the electricalstimulation system, including one or more of the lead bodies 106 and thecontrol module 102, are typically implanted into the body of a patient.The electrical stimulation system can be used for a variety ofapplications including, but not limited to, brain stimulation, neuralstimulation, spinal cord stimulation, muscle stimulation, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 134 are formed from one or more of: platinum, platinumiridium, palladium, palladium rhodium, or titanium. The number ofelectrodes 134 in each array 133 may vary. For example, there can betwo, four, six, eight, ten, twelve, fourteen, sixteen, or moreelectrodes 134. As will be recognized, other numbers of electrodes 134may also be used.

The electrodes of the one or more lead bodies 106 are typically disposedin, or separated by, a non-conductive, biocompatible material such as,for example, silicone, polyurethane, polyetheretherketone (“PEEK”),epoxy, and the like or combinations thereof. The lead bodies 106 may beformed in the desired shape by any process including, for example,molding (including injection molding), casting, and the like. Thenon-conductive material typically extends from the distal end of the oneor more lead bodies 106 to the proximal end of each of the one or morelead bodies 106.

Terminals (e.g., 210 in FIGS. 2A-2B) are typically disposed along theproximal end of the one or more lead bodies 106 of the electricalstimulation system 100 (as well as any splitters, lead extensions,adaptors, or the like) for electrical connection to correspondingconnector contacts (e.g., 214 in FIGS. 2A-2B, and 240 in FIG. 2B). Theconnector contacts are disposed in connectors (e.g., 144 in FIGS. 1-2B;and 222 in FIG. 2B) which, in turn, are disposed on, for example, thecontrol module 102 (or a lead extension, a splitter, an adaptor, or thelike). Electrically conductive wires, cables, or the like (not shown)extend from the terminals to the electrodes 134. Typically, one or moreelectrodes 134 are electrically coupled to each terminal. In at leastsome embodiments, each terminal is only connected to one electrode 134.

The electrically conductive wires (“conductors”) may be embedded in thenon-conductive material of the lead body 106 or can be disposed in oneor more lumens (not shown) extending along the lead body 106. In someembodiments, there is an individual lumen for each conductor. In otherembodiments, two or more conductors extend through a lumen. There mayalso be one or more lumens (not shown) that open at, or near, theproximal end of the lead body 106, for example, for inserting a styletto facilitate placement of the lead body 106 within a body of a patient.Additionally, there may be one or more lumens (not shown) that open at,or near, the distal end of the lead body 106, for example, for infusionof drugs or medication into the site of implantation of the one or morelead bodies 106. In at least one embodiment, the one or more lumens areflushed continually, or on a regular basis, with saline, epidural fluid,or the like. In at least some embodiments, the one or more lumens arepermanently or removably sealable at the distal end.

FIG. 2A is a schematic side view of one embodiment of a proximal end ofone or more elongated devices 200 configured and arranged for couplingto one embodiment of the control module connector 144. The one or moreelongated devices may include, for example, the lead body 106, one ormore intermediate devices (e.g., the splitter 107 of FIG. 1, the leadextension 224 of FIG. 2B, an adaptor, or the like or combinationsthereof), or a combination thereof.

The control module connector 144 defines at least one port into which aproximal end of the elongated device 200 can be inserted, as shown bydirectional arrows 212 a and 212 b. In FIG. 2A (and in other figures),the connector housing 112 is shown having two ports 204 a and 204 b. Theconnector housing 112 can define any suitable number of ports including,for example, one, two, three, four, five, six, seven, eight, or moreports.

The control module connector 144 also includes a plurality of connectorcontacts, such as connector contact 214, disposed within each port 204 aand 204 b. When the elongated device 200 is inserted into the ports 204a and 204 b, the connector contacts 214 can be aligned with a pluralityof terminals 210 disposed along the proximal end(s) of the elongateddevice(s) 200 to electrically couple the control module 102 to theelectrodes (134 of FIG. 1) disposed at a distal end of the lead 103.Examples of connectors in control modules are found in, for example,U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporated byreference.

FIG. 2B is a schematic side view of another embodiment of the electricalstimulation system 100. The electrical stimulation system 100 includes alead extension 224 that is configured and arranged to couple one or moreelongated devices 200 (e.g., the lead body 106, the splitter 107, anadaptor, another lead extension, or the like or combinations thereof) tothe control module 102. In FIG. 2B, the lead extension 224 is showncoupled to a single port 204 defined in the control module connector144. Additionally, the lead extension 224 is shown configured andarranged to couple to a single elongated device 200. In alternateembodiments, the lead extension 224 is configured and arranged to coupleto multiple ports 204 defined in the control module connector 144, or toreceive multiple elongated devices 200, or both.

A lead extension connector 222 is disposed on the lead extension 224. InFIG. 2B, the lead extension connector 222 is shown disposed at a distalend 226 of the lead extension 224. The lead extension connector 222includes a connector housing 228. The connector housing 228 defines atleast one port 230 into which terminals 210 of the elongated device 200can be inserted, as shown by directional arrow 238. The connectorhousing 228 also includes a plurality of connector contacts, such asconnector contact 240. When the elongated device 200 is inserted intothe port 230, the connector contacts 240 disposed in the connectorhousing 228 can be aligned with the terminals 210 of the elongateddevice 200 to electrically couple the lead extension 224 to theelectrodes (134 of FIG. 1) disposed along the lead (103 in FIG. 1).

In at least some embodiments, the proximal end of the lead extension 224is similarly configured and arranged as a proximal end of the lead 103(or other elongated device 200). The lead extension 224 may include aplurality of electrically conductive wires (not shown) that electricallycouple the connector contacts 240 to a proximal end 248 of the leadextension 224 that is opposite to the distal end 226. In at least someembodiments, the conductive wires disposed in the lead extension 224 canbe electrically coupled to a plurality of terminals (not shown) disposedalong the proximal end 248 of the lead extension 224. In at least someembodiments, the proximal end 248 of the lead extension 224 isconfigured and arranged for insertion into a connector disposed inanother lead extension (or another intermediate device). In otherembodiments (and as shown in FIG. 2B), the proximal end 248 of the leadextension 224 is configured and arranged for insertion into the controlmodule connector 144.

Turning to FIGS. 7-8E, in some embodiments leads (e.g., percutaneousleads) are used in electrical stimulation systems designed for brainstimulation. FIG. 7 illustrates one embodiment of a device 700 for brainstimulation. The device includes a lead 710, a plurality of electrodes725 disposed at least partially about a circumference of the lead 710, aplurality of terminals 735, a connector 732 for connection of theelectrodes to a control unit, and a stylet 740 for assisting ininsertion and positioning of the lead in the patient's brain. The stylet740 can be made of a rigid material. Examples of suitable materials forthe stylet include, but are not limited to, tungsten, stainless steel,and plastic. The stylet 740 may have a handle 750 to assist insertioninto the lead 710, as well as rotation of the stylet 740 and lead 710.The connector 732 fits over a proximal end of the lead 710, afterremoval of the stylet 740.

The control unit (not shown) is typically an implantable pulse generatorthat can be implanted into a patient's body, for example, below thepatient's clavicle area. The pulse generator can have, for example,eight stimulation channels which may be independently programmable tocontrol the magnitude of the current stimulus from each channel. In somecases the pulse generator can have more or fewer than eight stimulationchannels (e.g., 4-, 6-, 16-, 32-, or more stimulation channels). Thecontrol unit can have one, two, three, four, or more connector ports,for receiving the plurality of terminals 735 at the proximal end of thelead 710.

In one example of operation, access to the desired position in the braincan be accomplished by drilling a hole in the patient's skull or craniumwith a cranial drill (commonly referred to as a burr), and coagulatingand incising the dura mater, or brain covering. The lead 710 can beinserted into the cranium and brain tissue with the assistance of thestylet 740. The lead 710 can be guided to the target location within thebrain using, for example, a stereotactic frame and a microdrive motorsystem. In some embodiments, the microdrive motor system can be fully orpartially automatic. The microdrive motor system may be configured toperform one or more the following actions (alone or in combination):insert the lead 710, retract the lead 710, or rotate the lead 710.

In some embodiments, measurement devices coupled to the muscles or othertissues stimulated by the target neurons, or a unit responsive to thepatient or clinician, can be coupled to the control unit or microdrivemotor system. The measurement device, user, or clinician can indicate aresponse by the target muscles or other tissues to the stimulation orrecording electrode(s) to further identify the target neurons andfacilitate positioning of the stimulation electrode(s). For example, ifthe target neurons are directed to a muscle experiencing tremors, ameasurement device can be used to observe the muscle and indicatechanges in tremor frequency or amplitude in response to stimulation ofneurons. Alternatively, the patient or clinician can observe the muscleand provide feedback.

The lead 710 for deep brain stimulation can include stimulationelectrodes, recording electrodes, or both. In at least some embodiments,the lead 710 is rotatable so that the stimulation electrodes can bealigned with the target neurons after the neurons have been locatedusing the recording electrodes.

Stimulation electrodes may be disposed on the circumference of the lead710 to stimulate the target neurons. Stimulation electrodes may bering-shaped so that current projects from each electrode equally inevery direction from the position of the electrode along a length of thelead 710. Ring electrodes typically do not enable stimulus current to bedirected from only a limited angular range around of the lead. Segmentedelectrodes, however, can be used to direct stimulus current to aselected angular range around the lead. When segmented electrodes areused in conjunction with an implantable pulse generator that deliversconstant current stimulus, current steering can be achieved to moreprecisely deliver the stimulus to a position around an axis of the lead(i.e., radial positioning around the axis of the lead).

To achieve current steering, segmented electrodes can be utilized inaddition to, or as an alternative to, ring electrodes. Though thefollowing description discusses stimulation electrodes, it will beunderstood that all configurations of the stimulation electrodesdiscussed may be utilized in arranging recording electrodes as well.

The lead 700 includes a lead body 710, one or more optional ringelectrodes 720, and a plurality of sets of segmented electrodes 730. Thelead body 710 can be formed of a biocompatible, non-conducting materialsuch as, for example, a polymeric material. Suitable polymeric materialsinclude, but are not limited to, silicone, polyurethane, polyurea,polyurethane-urea, polyethylene, or the like. Once implanted in thebody, the lead 700 may be in contact with body tissue for extendedperiods of time. In at least some embodiments, the lead 700 has across-sectional diameter of no more than 1.5 mm and may be in the rangeof 0.5 to 1.5 mm. In at least some embodiments, the lead 700 has alength of at least 10 cm and the length of the lead 700 may be in therange of 10 to 70 cm.

The electrodes can be made using a metal, alloy, conductive oxide, orany other suitable conductive biocompatible material. Examples ofsuitable materials include, but are not limited to, platinum, platinumiridium alloy, iridium, titanium, tungsten, palladium, palladiumrhodium, or the like. Preferably, the electrodes are made of a materialthat is biocompatible and does not substantially corrode under expectedoperating conditions in the operating environment for the expectedduration of use.

Each of the electrodes can either be used or unused (OFF). When theelectrode is used, the electrode can be used as an anode or cathode andcarry anodic or cathodic current. In some instances, an electrode mightbe an anode for a period of time and a cathode for a period of time.

Stimulation electrodes in the form of ring electrodes 720 can bedisposed on any part of the lead body 710, usually along a distal endportion of the lead 700. In FIG. 7, the lead 700 includes two ringelectrodes 720. Any number of ring electrodes 720 can be disposed alongthe length of the lead body 710 including, for example, one, two three,four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen,fourteen, fifteen, sixteen or more ring electrodes 720. It will beunderstood that any number of ring electrodes can be disposed along thelength of the lead body 710. In some embodiments, the ring electrodes720 are substantially cylindrical and wrap around the entirecircumference of the lead body 710. In some embodiments, the outerdiameters of the ring electrodes 720 are substantially equal to theouter diameter of the lead body 710. The length of the ring electrodes720 may vary according to the desired treatment and the location of thetarget neurons. In some embodiments the length of the ring electrodes720 are less than or equal to the diameters of the ring electrodes 720.In other embodiments, the lengths of the ring electrodes 720 are greaterthan the diameters of the ring electrodes 720. As discussed in moredetail below, the distal-most ring electrode 720 may be a tip electrode(see e.g., tip electrode 820 a of FIG. 8E) which covers most, or all, ofthe distal tip of the lead.

Deep brain stimulation leads may include one or more sets of segmentedelectrodes. Segmented electrodes may provide for superior currentsteering than ring electrodes because target structures in deep brainstimulation are not typically symmetric about the axis of the distalelectrode array. Instead, a target may be located on one side of a planerunning through the axis of the lead. Through the use of a radiallysegmented electrode array (“RSEA”), current steering can be performednot only along a length of the lead but also around a circumference ofthe lead. This provides precise three-dimensional targeting and deliveryof the current stimulus to neural target tissue, while potentiallyavoiding stimulation of other tissue. Examples of leads with segmentedelectrodes include U.S. Patent Application Publication Nos.2010/0268298; 2011/0005069; 2011/0130803; 2011/0130816; 2011/0130817;2011/0130818; 2011/0078900; 2011/0238129; 2012/0016378; 2012/0046710;2012/0071949; 2012/0165911; 2012/197375; 2012/0203316; 2012/0203320;7012/0203321 all of which are incorporated herein by reference.

The lead 700 is shown having a plurality of segmented electrodes 730.Any number of segmented electrodes 730 may be disposed on the lead body710 including, for example, one, two three, four, five, six, seven,eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteenor more segmented electrodes 730. It will be understood that any numberof segmented electrodes 730 may be disposed along the length of the leadbody 710. A segmented electrode 730 typically extends only 75%, 67%,60%, 50%, 40%, 33%, 25%, 20%, 17%, 15%, or less around the circumferenceof the lead.

The segmented electrodes 730 may be grouped into sets of segmentedelectrodes, where each set is disposed around a circumference of thelead 700 at a particular longitudinal portion of the lead 700. The lead700 may have any number segmented electrodes 730 in a given set ofsegmented electrodes. The lead 700 may have one, two, three, four, five,six, seven, eight, or more segmented electrodes 730 in a given set. Inat least some embodiments, each set of segmented electrodes 730 of thelead 700 contains the same number of segmented electrodes 730. Thesegmented electrodes 730 disposed on the lead 700 may include adifferent number of electrodes than at least one other set of segmentedelectrodes 730 disposed on the lead 700.

The segmented electrodes 730 may vary in size and shape. In someembodiments, the segmented electrodes 730 are all of the same size,shape, diameter, width or area or any combination thereof. In someembodiments, the segmented electrodes 730 of each circumferential set(or even all segmented electrodes disposed on the lead 700) may beidentical in size and shape.

Each set of segmented electrodes 730 may be disposed around thecircumference of the lead body 710 to form a substantially cylindricalshape around the lead body 710. The spacing between individualelectrodes of a given set of the segmented electrodes may be the same,or different from, the spacing between individual electrodes of anotherset of segmented electrodes on the lead 700. In at least someembodiments, equal spaces, gaps or cutouts are disposed between eachsegmented electrode 730 around the circumference of the lead body 710.In other embodiments, the spaces, gaps or cutouts between the segmentedelectrodes 730 may differ in size or shape. In other embodiments, thespaces, gaps, or cutouts between segmented electrodes 730 may be uniformfor a particular set of the segmented electrodes 730, or for all sets ofthe segmented electrodes 730. The sets of segmented electrodes 730 maybe positioned in irregular or regular intervals along a length the leadbody 710.

Conductor wires that attach to the ring electrodes 720 or segmentedelectrodes 730 extend along the lead body 710. These conductor wires mayextend through the material of the lead 700 or along one or more lumensdefined by the lead 700, or both. The conductor wires are presented at aconnector (via terminals) for coupling of the electrodes 720, 730 to acontrol unit (not shown).

When the lead 700 includes both ring electrodes 720 and segmentedelectrodes 730, the ring electrodes 720 and the segmented electrodes 730may be arranged in any suitable configuration. For example, when thelead 700 includes two sets of ring electrodes 720 and two sets ofsegmented electrodes 730, the ring electrodes 720 can flank the two setsof segmented electrodes 730 (see e.g., FIG. 7). Alternately, the twosets of ring electrodes 720 can be disposed proximal to the two sets ofsegmented electrodes 730 (see e.g., FIG. 8C), or the two sets of ringelectrodes 720 can be disposed distal to the two sets of segmentedelectrodes 730 (sec e.g., FIG. 8D). One of the ring electrodes can be atip electrode (see, tip electrode 820 a of FIG. 8E). It will beunderstood that other configurations are possible as well (e.g,alternating ring and segmented electrodes, or the like).

By varying the location of the segmented electrodes 730, differentcoverage of the target neurons may be selected. For example, theelectrode arrangement of FIG. 8C may be useful if the physiciananticipates that the neural target will be closer to a distal tip of thelead body 710, while the electrode arrangement of FIG. 8D may be usefulif the physician anticipates that the neural target will be closer to aproximal end of the lead body 710.

Any combination of ring electrodes 720 and segmented electrodes 730 maybe disposed on the lead 700. For example, the lead may include a firstring electrode 720, two sets of segmented electrodes; each set formed offour segmented electrodes 730, and a final ring electrode 720 at the endof the lead. This configuration may simply be referred to as a 1-4-4-1configuration (FIGS. 8A and 8E). It may be useful to refer to theelectrodes with this shorthand notation. Thus, the embodiment of FIG. 8Cmay be referred to as a 1-1-4-4 configuration, while the embodiment ofFIG. 8D may be referred to as a 4-4-1-1 configuration. Other electrodeconfigurations include, for example, a 2-2-2-2 configuration, where foursets of segmented electrodes are disposed on the lead, and a 4-4configuration, where two sets of segmented electrodes, each having foursegmented electrodes 730 are disposed on the lead. Another electrodeconfiguration is a 1-3-3-1 configuration with two sets of segmentedelectrodes, each set containing three electrodes disposed around thecircumference of the lead, flanked by two ring electrodes or a ringelectrode and a tip electrode. In some embodiments, the lead includes 16electrodes. Possible configurations for a 16-electrode lead include, butare not limited to 4-4-4-4; 8-8; 3-3-3-3-3-1 (and all rearrangements ofthis configuration); and 7-7-7-7-2-7-7-7.

In some embodiments, measurement devices coupled to the muscles or othertissues stimulated by the target neurons or a unit responsive to thepatient or clinician can be coupled to the control unit or microdrivemotor system. The measurement device, user, or clinician can indicate aresponse by the target muscles or other tissues to the stimulation orrecording electrodes to further identify the target neurons andfacilitate positioning of the stimulation electrodes. For example, ifthe target neurons are directed to a muscle experiencing tremors, ameasurement device can be used to observe the muscle and indicatechanges in tremor frequency or amplitude in response to stimulation ofneurons. Alternatively, the patient or clinician may observe the muscleand provide feedback.

The reliability and durability of the lead will depend heavily on thedesign and method of manufacture. Fabrication techniques discussed belowprovide methods that can produce manufacturable and reliable leads.

When the lead 700 includes a plurality of sets of segmented electrodes730, it may be desirable to form the lead 700 such that correspondingelectrodes of different sets of segmented electrodes 730 arelongitudinally aligned with one another along the length of the lead 700(see e.g, the segmented electrodes 730 shown in FIG. 7). Longitudinalalignment between corresponding electrodes of different sets ofsegmented electrodes 730 along the length of the lead 700 may reduceuncertainty as to the location or orientation between correspondingsegmented electrodes of different sets of segmented electrodes.Accordingly, it may be beneficial to form electrode arrays such thatcorresponding electrodes of different sets of segmented electrodes alongthe length of the lead 700 are longitudinally aligned with one anotherand do not circumferentially shift in relation to one another duringmanufacturing of the lead 700.

In other embodiments, individual electrodes in the two sets of segmentedelectrodes 730 are staggered (see, FIG. 8B) relative to one anotheralong the length of the lead body 710. In some cases, the staggeredpositioning of corresponding electrodes of different sets of segmentedelectrodes along the length of the lead 700 may be designed for aspecific application.

FIGS. 8A-8E illustrate leads 800 with segmented electrodes 830, optionalring electrodes 820 or tip electrodes 820 a, and a lead body 810. Thesets of segmented electrodes 830 include either two (FIG. 8B) or four(FIGS. 8A, 8C, and 8D) or any other number of segmented electrodesincluding, for example, three, five, six, or more.

Any other suitable arrangements of segmented electrodes can be used. Asan example, arrangements in which segmented electrodes are arrangedhelically with respect to each other. One embodiment includes a doublehelix.

As mentioned above (FIG. 8E), a tip electrode can be used in combinationwith one or more circumferential electrodes (e.g., one or more ringelectrodes, one or more segmented electrodes, or any combination of oneor more ring electrodes and one or more segmented electrodes). In atleast some embodiments, a tip electrode may be selected to have thesame, or substantially the same, surface area as one or more ringelectrodes of the lead.

Turning to FIG. 3, a tip electrode can be designed to improve retentionof the tip electrode on a lead, or to prevent undesired rotation of thetip electrode relative to the lead body, or both. As herein described, atip electrode includes one or more lead-retention features, such as oneor more channels, side apertures, or longitudinal grooves, that aredefined along a body of the tip electrode and that improve retention ofthe tip electrode on the lead, or that prevent undesired rotation of thetip electrode relative to the lead body, or both.

FIG. 3 illustrates a side view of one embodiment of a distal end portion316 and a proximal end portion 318 of a lead body 306 of a lead 303. Thedistal end portion 316 of the lead body 306 includes a distal tip 320.Terminals, such as terminal 310, are disposed along the proximal endportion 318 of the lead body 306.

A tip electrode 350 is disposed along the distal tip 320 of the leadbody 306. In at least some embodiments, the tip electrode 350 has arounded distal end. In at least some embodiments, the tip electrode 350has a closed distal end. Circumferential electrodes 334 are disposedalong the distal end portion 316 of the lead body 306. In FIG. 3, thecircumferential electrodes 334 include a ring electrode 334 a andmultiple segmented electrodes 334 b.

Any suitable number of circumferential electrodes 334 can be disposedalong the distal end portion 316 of the lead including, for example,one, two, three, four, five, six, seven, eight, nine, ten, eleven,twelve, fourteen, sixteen, twenty, twenty-four, or more circumferentialelectrodes 334. The total number of circumferential electrodes 334 caninclude any combination of ring electrodes and segmented electrodes,including all ring electrodes and no segmented electrodes, or allsegmented electrodes and no ring electrodes.

The segmented electrodes 334 b are typically grouped into sets ofsegmented electrodes that are disposed around a particular circumferenceof the lead body 306 and that are physically and electrically isolatedfrom one another. A set of segmented electrodes 334 b can include anysuitable number of segmented electrodes including, for example, two,three, four, five, six, or more segmented electrodes. In at least someembodiments, a single segmented electrode is disposed around a portionof a particular circumference of the lead body that is not part of a setof segmented electrodes.

In at least some embodiments, the circumferential electrodes 334 areisodiametric with the lead body 306. In at least some embodiments, thetip electrode 350 is isodiametric with the lead body 306. In at leastsome embodiments, the circumferential electrodes 334 and the tipelectrode 350 are each isodiametric with the lead body 306.

The circumferential electrodes 334 can be disposed along the distal endportion 316 of the lead body 306 in any suitable configuration. In atleast some embodiments, the distal-most circumferential electrode 334 isa segmented electrode 334 b. In at least some other embodiments, thedistal-most circumferential electrode 334 is a ring electrode 334 a.

In at least some embodiments, the lead body 306 is formed by molding thelead body 306 between the circumferential electrodes 334 and, at leastin some embodiments, between the circumferential electrodes 334 and theterminals 310. The material of the lead body 306 can also be moldedbetween the distal-most circumferential electrode 334 and the tipelectrode 350.

During the molding process, the material that will form the lead bodycan flow into an internal lumen (470 in FIGS. 4A-4B) of the tipelectrode 350. Any molding process can be used including, but notlimited to, injection molding. The lead body 306 can be formed of anymaterial that can be molded by flowing the material around the othercomponents and then solidify the material to form the lead body. Anysuitable process can be used to solidify the material including, but notlimited to, cooling the material, photo-curing, heat curing,cross-linking, and the like. Examples of suitable materials can includesilicone, polyurethane, polyetheretherketone, epoxy, and the like. As anexample, the methods for forming a lead with segmented electrodesdisclosed in U.S. Patent Application Publication No. 2011/0078900,incorporated herein by reference, can be modified to include a tipelectrode (by, for example, replacing the distal-most ring electrode inFIGS. 7A-7E with a tip electrode).

FIG. 4A illustrates a schematic perspective view of one embodiment ofthe tip electrode 350. FIG. 4B illustrates a schematic longitudinalcross-section of the tip electrode 350. The tip electrode 350 includesan electrode body 452 having an outer stimulating surface 454. Theelectrode body 452 has a proximal end 460, a distal end 462, alongitudinal length 466, and a circumference. At least a portion of theouter stimulating surface 454 of the electrode body 452 is exposed totissue, when the lead 303 is implanted, for providing stimulation topatient tissue.

The electrode body 452 can have any suitable cross-sectional shape alongan axis transverse to the longitudinal length 466. In at least someembodiments, the electrode body 452 has a round transversecross-sectional shape. In at least some embodiments, the distal end 462of the electrode body 452 is rounded along an axis parallel with thelongitudinal length 466. In at least some embodiments, the distal end462 of the electrode body 452 is closed.

The tip electrode 350 defines an internal lumen 470 having a lumensurface 471. The internal lumen 470 extends inwardly from an opening 472defined in the proximal end 460 of the electrode body 452. The internallumen 470 can extend inwardly from the opening 472 along any suitableportion of the longitudinal length 466 of the electrode body 452including, for example, at least 75%, 80%, 85%, 90%, 92%, 94%, 96%, 98%,or more of the longitudinal length 466 of the electrode body 452. Theinternal lumen 470 can have any suitable shape along a plane that istransverse to the longitudinal length of the tip electrode 350. In atleast some embodiments, the internal lumen 470 each has a roundtransverse shape.

The tip electrode defines one or more lead-retention features. In atleast some embodiments, one or more of the lead-retention features areat least partially formed along internal lumen surfaces of the tipelectrode. As mentioned above, when the lead body is formed, thematerial of the lead body flows into the internal lumen and solidifies.The one or more lead-retention features form shapes that, when materialof the lead body is flowed into and solidifies, are configured andarranged to facilitate retention of the tip electrode on the lead bodyof the resulting lead, or prevent undesired rotation of the tipelectrode relative to the lead body, or both.

In at least some embodiments, the tip electrode 350 defines multipleside apertures, such as side aperture 482, defined along the surface 471of the internal lumen 470. The side apertures 482 extend deeper into theelectrode body 452 than adjacent portions of the internal lumen 470. Inother words, the side apertures 482 extend radially outward from theinternal lumen. The side apertures 482 are configured and arranged tofacilitate retention of the tip electrode 350 on the lead body 306 andalso to resist rotation of the tip electrode 350 around the lead body306.

Any suitable number of side apertures can be defined in the internallumen including, for example, two, three, four, five, six, seven, eight,nine, ten, eleven, twelve, or more side apertures 482. The sideapertures can be defined along any suitable locations of the internallumen. In at least some embodiments, at least one of the side aperturesis defined along the proximal end of the electrode body. In FIGS. 4A-4B,each of the side apertures 482 is shown defined along the proximal end460 of the electrode body 452. In at least some embodiments, the sideapertures are each defined along a plane transverse, or substantiallytransverse, to the longitudinal length of the electrode body.

In some embodiments, at least one of the side apertures extendspartially through a thickness of the electrode body 452 and does notopen to the outer stimulating surface 454. In at least some embodiments,at least one of the side apertures extends entirely through thethickness of the electrode body and opens to the outer stimulatingsurface. In other words, in at least some embodiments at least one ofthe side apertures is formed through the outer stimulating surface andopens into the internal lumen. In FIGS. 4A-4B, each of the sideapertures 482 is shown extending entirely through the thickness of theelectrode body 452 between the outer stimulating surface 454 and theinternal lumen 470.

When material of the lead body flows into the internal lumen 470, someof the material flows from the internal lumen 470 into the sideapertures 482. Once the material solidifies, the tip electrode 350 isprevented from rotating and from being removed from the lead body 306.In cases where one or more of the side apertures open to the outerstimulating surface 454, some material may flow out of side apertureduring manufacture and onto the outer stimulating surface of the tipelectrode. Any such material may subsequently be removed by grinding theouter stimulating surface 456 of the tip electrode 350.

In at least some embodiments, the tip electrode defines one or morechannels 486 extending along the surface 471 of the internal lumen 470.The one or more channels 486 extend deeper into the electrode body 452than adjacent portions of the internal lumen 470. In other words, theone or more channels 486 extend radially outward from the internallumen. The one or more channels 486 are configured and arranged tofacilitate retention of the tip electrode on the lead body. Whenmaterial of the lead body flows into the internal lumen 470, some of thematerial flowing into the internal lumen 470 flows into the one or morechannels 486. Once the material solidifies, the material resistsmovement of the tip electrode relative to the lead body.

Any suitable number of channels 486 can be defined in the internal lumenincluding, for example, one, two, three, four, five, or more channels486. The channels 486 can be defined along any suitable locations of theinternal lumen.

In at least some embodiments, the one or more channels 486 extend alongat least a portion of the circumference of the electrode body 452. In atleast some embodiments, at least one of the one or more channels 486extends at least 25%, 50%, or 75% around the circumference of the tipelectrode. In at least some embodiments, at least one of the one or morechannels 486 extends around the entire circumference of the tipelectrode. In at least some embodiments, at least one of the channels486 is defined along the proximal end of the tip electrode. In FIGS.4A-4B, a single channel 486 is shown extending around the entirecircumference of the tip electrode along a proximal end portion of thetip electrode.

In at least some embodiments, at least one of the one or more channels486 extends through at least a portion of the electrode body 452 alongwhich at least one of the side apertures 482 also extends. In otherwords, at least one of the one or more channels 486 intersects at leastone of the side apertures 482. In which case, the one or more sideapertures 482 may include multiple thicknesses. For example, FIG. 4Bshows the channel 486 extending along, a distal portion of each ofmultiple side apertures 482. In FIG. 4B, the channel 486 is shownextending through only a portion of a thickness of the electrode body452, while the side apertures 482 extend entirely through the thicknessof the electrode body 452. Thus, the side apertures 482 each have afirst length 488 along a proximal portion of each of the side apertures482 and a second length 490 along a distal portion of each of the sideapertures 482, where the first length 488 is different than the secondlength 490.

A tip-electrode conductor (not shown) is attached, welded, soldered, orotherwise electrically coupled to the tip electrode 350. The coupling ofthe tip-electrode conductor may occur prior to forming the lead body306. The tip-electrode conductor, like other conductors in the lead,extends along the lead and is electrically coupled to one of theterminals disposed along the proximal end portion of the lead. In someembodiments, the tip-electrode conductor is coupled to the tip electrode350 along the surface 471 of the internal lumen 470.

In at least some embodiments, the lead-retention features include one ormore longitudinal grooves in addition to, or in lieu of the one or moreside apertures shown in FIGS. 3-4B. FIG. 5A illustrates a schematicperspective view of one embodiment of a tip electrode 550. FIG. 5Billustrates a schematic longitudinal cross-section of the tip electrode550. The tip electrode 550 is configured and arranged for attaching tothe distal tip of a lead, such as the lead 303 of FIG. 3. The tipelectrode 550 includes an electrode body 552 having an outer stimulatingsurface 554. The electrode body 552 has a proximal end 560, a distal end562, a longitudinal length 566, and a circumference. At least a portionof the outer stimulating surface 554 of the electrode body 552 isexposed to tissue, when the lead 303 is implanted, for providingstimulation to patient tissue.

The electrode body 552 can have any suitable cross-sectional shape alongan axis transverse to the longitudinal length 466. In at least someembodiments, the electrode body 552 has a round transversecross-sectional shape. In at least some embodiments, the distal end 562of the electrode body 552 is rounded along an axis parallel with thelongitudinal length 566. In at least some embodiments, the distal end562 of the electrode body 552 is closed.

The tip electrode 550 defines an internal lumen 570 having a lumensurface 571. The internal lumen 570 extends inwardly from an opening 572defined in the proximal end 560 of the electrode body 552. The internallumen 570 can extend inwardly from the opening 572 along any suitableportion of the longitudinal length 566 of the electrode body 552including, for example, at least 75%, 80%, 85%, 90%, 92%, 94%, 96%, 98%,or more of the longitudinal length 566 of the electrode body 552. Theinternal lumen 570 can have any suitable shape along a plane that istransverse to the longitudinal length of the tip electrode 550. In atleast some embodiments, the internal lumen 570 each has a roundtransverse shape.

The tip electrode defines one or more lead-retention features. Asmentioned above, when the lead body is formed, the material of the leadbody flows into the internal lumen and solidifies. The one or morelead-retention features form shapes that, when material of the lead bodyis flowed into and solidifies, are configured and arranged to facilitateretention of the tip electrode on the lead body of the resulting lead,or prevent undesired rotation of the tip electrode relative to the leadbody, or both.

In at least some embodiments, the tip electrode 550 defines multiplelongitudinal grooves, such as longitudinal groove 594, defined along thesurface 571 of the internal lumen 570. The longitudinal grooves 594extend deeper into the electrode body 552 than adjacent portions of theinternal lumen 570. In other words, the one or more longitudinal grooves594 extend radially outward from the internal lumen. The longitudinalgrooves 594 are configured and arranged to facilitate retention of thetip electrode 550 on the lead body 306 and also to resist rotation ofthe tip electrode 550 around the lead body 306.

Any suitable number of longitudinal grooves can be defined along theinternal lumen including, for example, two, three, four, five, six,seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen,sixteen, seventeen, eighteen, nineteen, twenty, or more longitudinalgrooves 594. The longitudinal grooves can be defined along any suitablelocations of the internal lumen. In at least some embodiments, at leastone of the longitudinal grooves is defined along the proximal end of theelectrode body. In FIGS. 5A-5B, each of the longitudinal grooves 594 isshown defined along the proximal end 560 of the electrode body 552.

The longitudinal grooves 594 can be any suitable shape. In at least someembodiments, the longitudinal grooves are elongated such that thelongitudinal grooves have lengths that are at least 2, 3, 4, 5, 10, 15,20, or more times widths of the longitudinal grooves. In at least someembodiments, the longitudinal grooves each extend parallel to oneanother. In at least some embodiments, at least one of the longitudinalgrooves extends in a different direction than at least one of the otherlongitudinal grooves. In at least some embodiments, the longitudinalgrooves each extend in a direction that is parallel, or substantiallyparallel, to the longitudinal length of the tip electrode.

The longitudinal grooves can be of any suitable length. In someembodiments, the longitudinal grooves extend an entire length of theinternal lumen. In other embodiments, the longitudinal grooves extendless than an entire length of the internal lumen. In at least someembodiments, the longitudinal grooves extend at least 25%, 30%, 35%.40%, 45%, 50%, 60%, or more, of the longitudinal length of the electrodebody. In at least some embodiments, the longitudinal grooves extend fromthe opening 572 of the internal lumen.

In some embodiments, at least one of the longitudinal grooves extendspartially through a thickness of the electrode body 552 and does notopen to the outer stimulating surface 554. In at least some embodiments,at least one of the longitudinal grooves extends entirely through thethickness of the electrode body and opens to the outer stimulatingsurface. In other words, in at least some embodiments at least one ofthe longitudinal grooves is formed through the outer stimulating surfaceand opens into the internal lumen. In FIGS. 5A-5B, each of thelongitudinal grooves 594 are shown extending partially through thethickness of the electrode body 552 from the surface of the internallumen 570 and do not open to the outer stimulating surface 554.

When material of the lead body flows into the internal lumen 570, someof the material flows from the internal lumen 570 into the longitudinalgrooves 594. Once the material solidifies, the tip electrode 550 isprevented from rotating and from being removed from the lead body 306.In cases where one or more of the longitudinal channels open to theouter stimulating surface 554, some material may flow out oflongitudinal channels during manufacture and onto the outer stimulatingsurface of the tip electrode. Any such material may subsequently beremoved by grinding the outer stimulating surface 556 of the tipelectrode 550.

In at least some embodiments, the tip electrode defines one or morechannels 586 extending along the surface 571 of the internal lumen 570.The one or more channels 586 extend deeper into the electrode body 552than adjacent portions of the internal lumen 570. In other words, theone or more channels 586 extend radially outward from the internallumen. The one or more channels 586 are configured and arranged tofacilitate retention of the tip electrode on the lead body. Whenmaterial of the lead body flows into the internal lumen 570, some of thematerial flowing into the internal lumen 570 flows into the one or morechannels 586. Once the material solidifies, the material resistsmovement of the tip electrode relative to the lead body.

Any suitable number of channels 586 can be defined along the internallumen including, for example, one, two, three, four, five, or morechannels 586. The channels 586 can be defined along any suitableportions of the internal lumen. In at least some embodiments, at leastone of the one or more channels 586 extends through at least a portionof the electrode body 552 along which at least one of the longitudinalgrooves 594 also extends. In other words, at least one of the one ormore channels 586 intersects at least one of the longitudinal grooves594.

In at least some embodiments, the one or more channels 586 extend alongat least a portion of the circumference of the electrode body 552. In atleast some embodiments, at least one of the one or more channels 586extends at least 25%, 50%, or 75% around the circumference of the tipelectrode. In at least some embodiments, at least one of the one or morechannels 586 extends around the entire circumference of the tipelectrode. In at least some embodiments, at least one of the channels586 is defined along the proximal end of the electrode body. In FIGS.5A-5B, a single channel 586 is shown extending around the entirecircumference of the tip electrode along the proximal end portion of thetip electrode.

In at least some embodiments, the one or more channels 586 extend moredeeply into the surface 571 of the internal lumen 570 than at least oneof the longitudinal grooves 594. In which case, for example, when achannel intersects a particular longitudinal groove, and when thechannel extends more deeply into the surface of the internal lumen thanthe longitudinal groove, the channel separates that longitudinal grooveinto a proximal portion and a distal portion. In FIGS. 5A-5B, the singlechannel 586 is shown extending around the entire circumference of theelectrode body 552 and extending deeper into the surface 571 of theinternal lumen 570 than the longitudinal grooves 594 such that each ofthe longitudinal grooves 594 is separated into a proximal portion and adistal portion.

A tip-electrode conductor (not shown) is attached, welded, soldered, orotherwise electrically coupled to the tip electrode 550. The coupling ofthe tip-electrode conductor may occur prior to forming the lead body306. The tip-electrode conductor, like other conductors in the lead,extends along the lead and is electrically coupled to one of theterminals disposed along the proximal end portion of the lead. In someembodiments, the tip-electrode conductor is coupled to the tip electrode550 along the surface 571 of the internal lumen 570.

FIG. 6 is a schematic overview of one embodiment of components of anelectrical stimulation system 600 including an electronic subassembly610 disposed within a control module. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the stimulator references citedherein.

Some of the components (for example, a power source 612, an antenna 618,a receiver 602, and a processor 604) of the electrical stimulationsystem can be positioned on one or more circuit boards or similarcarriers within a sealed housing of an implantable pulse generator, ifdesired. Any power source 612 can be used including, for example, abattery such as a primary battery or a rechargeable battery. Examples ofother power sources include super capacitors, nuclear or atomicbatteries, mechanical resonators, infrared collectors, thermally-poweredenergy sources, flexural powered energy sources, bioenergy powersources, fuel cells, bioelectric cells, osmotic pressure pumps, and thelike including the power sources described in U.S. Pat. No. 7,437,193incorporated herein by reference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 618 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 612 is a rechargeable battery, the battery may berecharged using the optional antenna 618, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 616 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. The processor604 is generally included to control the timing and electricalcharacteristics of the electrical stimulation system. For example, theprocessor 604 can, if desired, control one or more of the timing,frequency, strength, duration, and waveform of the pulses. In addition,the processor 604 can select which electrodes can be used to providestimulation, if desired. In some embodiments, the processor 604 selectswhich electrode(s) are cathodes and which electrode(s) are anodes. Insome embodiments, the processor 604 is used to identify which electrodesprovide the most useful stimulation of the desired tissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 608 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor604 is coupled to a receiver 602 which, in turn, is coupled to theoptional antenna 618. This allows the processor 604 to receiveinstructions from an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 618 is capable of receiving signals (e.g,RF signals) from an external telemetry unit 606 which is programmed bythe programming unit 608. The programming unit 608 can be external to,or part of, the telemetry unit 606. The telemetry unit 606 can be adevice that is worn on the skin of the user or can be carried by theuser and can have a form similar to a pager, cellular phone, or remotecontrol, if desired. As another alternative, the telemetry unit 606 maynot be worn or carried by the user but may only be available at a homestation or at a clinician's office. The programming unit 608 can be anyunit that can provide information to the telemetry unit 606 fortransmission to the electrical stimulation system 600. The programmingunit 608 can be part of the telemetry unit 606 or can provide signals orinformation to the telemetry unit 606 via a wireless or wiredconnection. One example of a suitable programming unit is a computeroperated by the user or clinician to send signals to the telemetry unit606.

The signals sent to the processor 604 via the antenna 618 and thereceiver 602 can be used to modify or otherwise direct the operation ofthe electrical stimulation system. For example, the signals may be usedto modify the pulses of the electrical stimulation system such asmodifying one or more of pulse duration, pulse frequency, pulsewaveform, and pulse strength. The signals may also direct the electricalstimulation system 600 to cease operation, to start operation, to startcharging the battery, or to stop charging the battery. In otherembodiments, the stimulation system does not include the antenna 618 orreceiver 602 and the processor 604 operates as programmed.

Optionally, the electrical stimulation system 600 may include atransmitter (not shown) coupled to the processor 604 and the antenna 618for transmitting signals back to the telemetry unit 606 or another unitcapable of receiving the signals. For example, the electricalstimulation system 600 may transmit signals indicating whether theelectrical stimulation system 600 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 604 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. An implantable electrical stimulation lead,comprising: a lead body having a proximal end portion, a distal endportion, a distal tip, and a longitudinal length: a plurality ofelectrodes disposed along the distal end portion of the lead body, theplurality of electrodes comprising a tip electrode disposed on thedistal tip of the lead body, the tip electrode comprising an electrodebody having an outer stimulating surface, a proximal end, a closeddistal end, a circumference, and a longitudinal length, an internallumen defined in the electrode body and extending inwardly from anopening in the proximal end of the electrode body, and a plurality ofside apertures formed through the outer stimulating surface and openinginto the internal lumen, wherein a portion of the lead body is disposedwithin the internal lumen and into the plurality of side aperturesthrough the opening in the proximal end of the electrode body, whereinthe portion of the lead body within the internal lumen and the pluralityof side apertures facilitates retention of the tip electrode on thedistal tip of the lead body; a plurality of terminals disposed along theproximal end portion of the lead body; and a plurality of conductorselectrically coupling the terminals to the electrodes.
 2. Theimplantable electrical stimulation lead of claim 1, wherein the tipelectrode further comprises a channel defined in the internal lumen, thechannel extending deeper into the electrode body than adjacent portionsof the internal lumen, the channel extending along at least 25% of thecircumference of the electrode body.
 3. The implantable electricalstimulation lead of claim 2, wherein the channel extends around theentire circumference of the electrode body.
 4. The implantableelectrical stimulation lead of claim 2, wherein the channel intersectsat least a portion of at least one of the plurality of side apertures.5. The implantable electrical stimulation lead of claim 2, wherein thechannel intersects at least a portion of each of the plurality of sideapertures.
 6. The implantable electrical stimulation lead of claim 1,wherein the plurality of side apertures comprises at least three sideapertures.
 7. The implantable electrical stimulation lead of claim 1,wherein the plurality of electrodes further comprises at least one ringelectrode.
 8. The implantable electrical stimulation lead of claim 1,wherein the plurality of electrodes further comprises at least onesegmented electrode.
 9. The implantable electrical stimulation lead ofclaim 8, wherein the at least one segmented electrode is a plurality ofsegmented electrodes divided into at least two sets of segmentedelectrodes with each set disposed at a different longitudinal positionalong the lead body.
 10. The implantable electrical stimulation lead ofclaim 1, wherein the internal lumen extends along at least 75% of thelongitudinal length of the electrode body.
 11. The implantableelectrical stimulation lead of claim 1, wherein the tip electrode isisodiametric with the lead body.
 12. The implantable electricalstimulation lead of claim 1, wherein the electrode body defines at leastone longitudinal groove formed along the internal lumen and extendingdeeper into the electrode body than adjacent portions of the internallumen, wherein each longitudinal groove extends along the internal lumenin a direction that is parallel to the longitudinal length of theelectrode body.
 13. The implantable electrical stimulation lead of claim12, wherein at least one of the at least one longitudinal groove extendsfrom the opening in the proximal end of the internal lumen.
 14. Theimplantable electrical stimulation lead of claim 12, wherein the atleast one longitudinal groove extend along at least 50% of thelongitudinal length of the electrode body.
 15. The implantableelectrical stimulation lead of claim 12, wherein the at least onelongitudinal groove is a plurality of longitudinal grooves.
 16. Theimplantable electrical stimulation lead of claim 12, wherein the tipelectrode further comprises a channel defined in the internal lumen, thechannel extending deeper into the electrode body than adjacent portionsof the internal lumen, the channel extending along at least 25% of thecircumference of the electrode body, wherein the channel intersects atleast a portion of at least one of the at least one longitudinal groove.17. An electrical stimulating system comprising: the implantableelectrical stimulation lead of claim 1; a control module coupleable tothe implantable electrical stimulation lead, the control modulecomprising a housing, and an electronic subassembly disposed in thehousing; and a connector for receiving the implantable electricalstimulation lead, the connector comprising a connector housing defininga port, the port configured and arranged for receiving the proximal endportion of the lead body of the implantable electrical stimulation lead,and a plurality of connector contacts disposed in the port, theplurality of connector contacts configured and arranged to couple to theplurality of terminals disposed along the proximal end portion of thelead body when the proximal end portion of the lead body is received bythe port.
 18. The electrical stimulation system of claim 17, wherein thecontrol module comprises the connector.
 19. The electrical stimulationsystem of claim 17, further comprising a lead extension coupleable toboth the implantable electrical stimulation lead and the control module,wherein the lead extension comprises the connector.
 20. A method ofstimulating a patient using an electrical stimulation lead, the methodcomprising: implanting the electrical stimulation lead of claim 1 intothe patient; and providing electrical stimulation to the patient usingthe electrodes of the electrical stimulation lead.